FDA 483 - SM Biomed Sdn Bhd - March 23, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of SM Biomed Sdn. Bhd. in Sungai Petani, Malaysia, revealed a significant issue regarding the validation of a printer used for imprinting critical information onto API templates. The firm lacked documented evidence that the specific printer in use had been validated, with a discrepancy noted between the validated printer's identification and the printer actually utilized. This indicates a potential control weakness in their labeling process for active pharmaceutical ingredients.
ID · e8e62394-9a21-453b-b51c-94b675170951